A rongeur is a hand held surgical instrument used to remove a small amount of body material for testing. A rongeur can be utilized to remove cartilage or other types of biomass and/or tissue from the knee, cervix, or vertebrae in a patient's back or other sites within the body. During the normal operation of a rongeur, blood, mucous, tissue, bone and other bio-burden can infiltrate and become trapped within the instrument. A rongeur includes interfacing surfaces and a cutting surface that can trap bio-burden during normal use and which may not be completely removed during the cleaning process. Entrapped bio-burden can inhibit the sterilization process and the sterility of the instrument after re-processing cannot be guaranteed. Also, unless the instrument is thoroughly dried after the sterilization cycle, waterborne pathogens can survive in inaccessible spaces and further result in a contaminated instrument. Use of a contaminated instrument creates an increased risk of a surgical infection to the patient.
Inadequate or improper cleaning and sterilization of surgical instruments has been documented by the Center for Disease Control (CDC) to be a major cause of surgical site infections (SSI's). A recent CDC publication, “Guideline for Prevention of Surgical Site Infection,” pointed out that SSI's are particularly troublesome because “one third involved organs and spaces accessed during the operation. When surgical patients with SSI's died, 77 percent of the deaths were reported to be related to the infection and the majority, 93 percent, were serious infections involving organs and spaces accessed during the operation.”
According to recent data collected by the CDC, the distribution of pathogens isolated from SSI's has remained stubbornly consistent over the last decade. This fact is especially disturbing in light of their observation that, “[a]dvances in infection control practices include improved operating room ventilation, sterilization methods and barriers, surgical techniques and availability of antimicrobial prophylaxis. Despite these activities, SSI's remain a substantial cause of morbidity and mortality among hospitalized patients.” Reusable surgical instruments (such as rongeurs) that are not, or cannot be, properly cleaned and sterilized are a major cause of these deep organ SSI's. The CDC further notes that “[i]nadequate cleaning and sterilization of surgical instruments has resulted in SSI outbreaks” and cites articles in Anesthesiology, MMWR and Journal of Hospital Infections in asserting this claim.
The April 2001 AORN Journal (Association of periOperative Registered Nurses) noted, “[d]econtamination is the first and most important step in the sterilization process. Inadequate cleaning of organic debris may result in retained organisms and make the sterilization process ineffective. Proper decontamination and removal of all possible biomaterial is essential. High bio-burden inhibits the sterilization process, and sterility cannot be guaranteed. If an improperly cleaned instrument is placed on the sterile field in the operating room, the sterile field should be considered contaminated, and appropriate steps to correct the problem should be taken. The un-sterile instrument and other instruments that may have come in contact with it should be removed from the operating room.”
New research in The Journal of the American Medical Association (JAMA) released Oct. 7, 2003 concluded, “[m]edical injuries in hospitals pose a significant threat to patients and incur substantial costs to society.” Hospital acquired infections (HAI's) top the list of medical injuries in both costs and additional days of hospitalization required. The largest risk to patients are infections acquired during surgery which “result in almost eleven additional days of hospital care at an extra cost of $57,727 as well as an increased risk of death of twenty two percent.” In April 2002, an article in Infection Control Today stated, “[o]ne concern that is getting more attention is the development of biofilms (a layer of microorganisms that contain a polysaccharide matrix) on instruments/medical devices or within instruments that cannot be taken apart or contain multiple complex contours (i.e., rasps, reamers, rongeurs, broaches or complex endoscopic instruments). The incorporation of pathogens in biofilms can protect the pathogen from concentrations of biocides that could otherwise kill or inhibit those organisms freely suspended in water. Biofilms provide a safe haven for organisms, thus creating the potential of cross contamination/infection.”
Once protected within a biofilm, bacteria are able to resist antibiotics at concentrations ranging from 1 to 1.5 thousand times higher than the concentrations used in conventional antibiotic therapy. As a consequence, biofilms are a source of serious and chronic infections. With the increasing emergence of antibiotic-resistant bacteria, biofilm-related chronic infections transmitted by non-sterile surgical instruments represent a highly complex and escalating medical problem.
The risk of a surgical infection caused by waterborne pathogens remaining inside a surgical instrument after the sterilization cycle has also been receiving increased attention. “The most common misconception in healthcare settings is that waterborne pathogens are not major contributors to infections,” says Joseph S. Cervia, Md., professor of Clinical Medicine at the Albert Einstein College of Medicine in New York (Infection Control Today, June 2005). Dr. Cervia goes on to point out, “modes of transmission for waterborne infections include contact from an improperly reprocessed medical device.”
In attempting to solve the problem of bio-burden and/or waterborne pathogens collecting on the internal interfacing surfaces of rongeurs, a number of techniques and rongeurs have been developed. Several styles of rongeurs have been developed that can be taken apart to expose all surfaces to the cleaning process. This approach can be effective if done properly by a skilled and knowledgeable re-processing technician. The down-side to taking apart rongeurs is that they can be difficult and time consuming to disassemble, manually clean and reassemble, not to mention the frequent problem of lost parts. If not properly reassembled, the rongeur will not operate properly and may require costly repair or replacement. Once reassembled and sterilized, the rongeur can still pose the risk of a surgical site infection (“SSI”) to a patient due to waterborne pathogens remaining inside the instrument in areas that cannot be properly dried after the sterilization cycle. While other approaches have been suggested involving the use of more complicated instruments, these approaches create new levels of manufacturing and user complexity.
Another problem associated with rongeurs is the inability to properly lubricate all of the contact surfaces without completely disassembling the instrument. This time consuming process is expensive and is frequently done by a professional instrument repair service requiring the instrument to be taken out of service. Lack of proper lubrication makes the instrument difficult, if not impossible, to use. Lack of proper lubrication inside the instrument causes galling of the metal and significantly shortens the life of the instrument.
Accordingly, there exists a need for a rongeur that improves and simplifies the cleaning, sterilization, drying and lubricating processes while still providing easy use thereof.